About this role
Regional Regulatory Affairs Lead, US at Neko Health. Location: New York, New York, United States. Role: setting strategy, managing submissions, building processes Requirements: 8+ years in medical device regulatory affairs with 5+ years on FDA-regulated devices; accountable lead on 510(k)/De Novo/PMA; direct FDA engagement; able to hold US Agent/Initial Importer/Distributor roles; experience building RA processes and teams; degree required; experience using AI for regulatory workflows. Category: Legal and Compliance Seniority: Senior Level Commitment: Full Time Workplace: Hybrid Languages: English